ML20129B890
| ML20129B890 | |
| Person / Time | |
|---|---|
| Site: | 07001717 |
| Issue date: | 11/30/1984 |
| From: | Brady N NORWALK HOSP., NORWALK, CT |
| To: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20129B724 | List: |
| References | |
| 03220, 3220, NUDOCS 8507290289 | |
| Download: ML20129B890 (24) | |
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Hospita November 30, 1984 United States Nuclear Regulatory Commission Region 1 641 Park Avenue King of Prussia, Pennsylvania 19406 Ati.ention : John E. Glenn, Ph.D.
RE:
License No. SNM - 1504 Renewal Materials Licensing Branch Gentlemen:
Request is made to renew license No. SNM-1504 authorizing the use of plutonium-238 nuclear pacemakers at this facility.
e The reasons for renewal are to:
1.
Continue to receive and implant nuclear pacemakers.
2.
Follow patients with implanted nuclear pacemakers and, 3.
Return explanted nuclear pacemakers to their manufacturer for proper disposal.
Please be advised that the manufacturer's pacemakers are as follows:
Manufacturer Model No.
Milligrams of Plutonium 238 Coratomic C-101 and C-101-P 250 each Medtronics 9,000 210 each
. Authorization for ten (10) Nuclear pacemakers of each manufacturer is requested.
The manufacturcr's NRC approved protocol will be followed.
Martin Krauthamer, M.D., Chief, Section of Cardiology, is the physician in charge of'the plutonium pacemaker program. The nuclear pacemakers will be used only by or under the direct supervision of Dr. Krauthamer.
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If there should be any questions, please contact me.
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C. Collica, M. Krauthamer, M.D., C. Palestro, M.D.
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PROCEDURE FOR IMPLANTING NUCLEAR-POWERED PACEMAKERS Both the hospital and the physicians must be licensed to implant Coratomic nuclear-powered pacemakers.
A suggested format for a license application is included as Exhibit IX in the Human Implantation Protocol for the Coratomic C-101-P Radioisotope Powered Cardiac Pacer, dated March 2, 1983.
As part of the license application, the physicians and the hospital must agree to follow the Human Implantation Protocol for the Coratomic C-101-P Radioisotope Powered Cardiac Pacer, dated March 2, 1983.
One provision of the protocol is that the physician or hospital and the patient must remain in contact with one another until the patient dies or until the Coratomic radioisotope-powered cardiac pacer is removed.
In the event of patient death or pacemaker removal, the pacemaker must be recovered by the physician or hospital and returned to Coratomic.
The requirements for patient follow-up contact and pacemaker recovery are' stated in sections 2, 3,
7 8, 9, 10, 11, 12, 13, and 14 of the C-101-P protocol.
Please note that Coratomic and the licensing agency (The licensing agency is usually the U. S. Nuclear Regulatory Commission.
In the case of agreement states, it is the state licensing agency.) must be notified of a patient death within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, and must be advised of loss of contact with a patient within 10 days.
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PROCEDURE.FOR IMPLANTING NUCLEAR-POWERED PACEMAKERS (continued).
The license application should be typed on the hospital's letterhead, and signed by.the hospital administrator, the hospital radiation safety. officer, and each of the physicians involved.
Then the license application is mailed to the
' licensing agency.
After the hospital receives their license, a copy should be.
. mailed to the Coratomic Data Center.
Coratomic must have a copy of the license on file before an isotopic-powered pacemaker can be shipped to the hospital.
6
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AGREEMENT STATES 1.
.2.
Arkansas 3.
ArizoUa
-4.
. California 5.
Colorada 6.
Florida 7.
Georgia 8.
Kansas 9.
Kentucky 10.
Louisiana 11 flaryland 12.
f4ississippi 13.
fiebraska 14.
fievada 15.
flew Hampshire 16.
flew York 17.
North Carolina 18.
fiorth Dakota 19.
Oregon 20.
South Carolina 21.
Tennessee 22.
Texas 23.
Washington If an Agreement. State,' application and Letter of Choice sent to the appropriate office in that state, instead of to the fl.R.C. for approval.
All government hospital licenses are sent to the fl.R.C. in Washington, 1
DC for approval, even if it is an Agreement State.
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HUMAN IMPLAf1TATI0f1 PROTOCOL FOR THE CORATOMIC C-101-P RADI0IS0 TOPE POUERED CARDIAC PACER March 2, 1983 l
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/aB CuratorT1IC ky P. O. 00X 434. INDIANA. PENNSYLVANIA 15701 Y
PHONE (412) 349-1811 TELEX 86 6658
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TABLE OF CONTENTS SUBJECT 1.
Description of the Pacer and Radionuclide Power Source 1
2.
Patient Selection.
2 3.
Follow-up and Reporting.
2
~4.
Implantation Procedures and Leads.
2 5.
Stimulation Threshold Measurements 2
6.
Sensing Threshold Measurements 3
7.
Registration and Implant Reports 3
8.
Follow-up Data 3
9.
Reports of Removal and Replacement 3
10.
Notification of Deaths, Adverse Reactions or Malf unc tions.
3 11.
Notification of Loss of Patient Contact.
4 12.
Information To and Consent From the Patient.
4 13.
Record Retention 5
14.
Accountability and Recovery.
5 Exhibit I
- References 7
Exhibit II
- Registration and Implantation Data Form.
8 Exhibit III
- Follow-up Data Form.
9 Exhibit IV
- Pacer Failure and Removal or Patient Death Form.
10 Exhibit V
- Informed Consent for Surgical Imolantation of Radioisotope Powered Cardiac Pacer 11 Exhibit VI
- Patient Identification Cards 12 Exhibit VII
- Donor Cards for Adults 13 Exhibit VIII
- Donor Cards for Minors 14 Exhibit IX
- Suggested Application Format for Nuclear Powered Pacemakers.
15 Exhibit X
- Instructions for Hospital or Clinic Telephone operators 16
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CORATOMIC C-101-P RADIOISOTOPE CARDIAC PACER PROTOCOL March 2, 1983 1.
Description of the Pacer and Radionuclide Power Source An extensive literature has arisen in connection with cardiac pacing, and selected references are-listed in Exhibit 1.
The physician responsible for pacer implantation is cognizant of these and other relevant references and has had extensive experience in the use of cardiac pacers.
The C-101-P pacer utilizes a programmable hybrid circuit, the pacing modes and operating parameters of which can be noninvasively changed using a Coratomic hand-held programmer.
It is electronically similar to programmable pacers which have been in use for many years.
While the unit is normally used as an R-wave inhibited (VVI) pacemaker, the implanting physician may elect to use the pacer for asynchronous (VOO) pacing when appro-priate indications are present.
The pacing rate is programmable at 13 settings ranging from 38 to 120 PPM.
Pulse current can be set to either 4 or 10 mA. ' Sensitivity is programmable to 1.5, 2.5, 4,
or 5 mv.
The pacer can be changed from its normal R-wave inhibited (VVI) mode to asynchronous (VCO) pacing by placing the sensitivity selector to its FR (Fixed Rate) setting.
The unit is hermetically sealed and shielded against electromagnetic interference.
It has an asynchronous
" magnet rate", identical to the programmed pacing rate, used to ascertain cardiac capture and for operational verification.
If high energy electromagnetic fields are present, the pacer will switch to a fixed rate rather than becoming inhibited.
The fuel used for the C-101-P is plutonium-238 in its oxidb form, pressed and sintered into a hard, ceramic pellet.
The isotopic battery has been so designed that excess electrical power is available at the end of a 40 year life.
The pacers have undergone extensive testing for efficacy, including excessive nochanical shock, impact, and vibration testing, and the nuclear fuel is contained in such a manner to prevent fuel release under any credible accident, including building or auto accident, fire, fall from an airplane, crushing, corrosion in sea water, or accidental cremation.
Data concerning radiation level, safety, and efficacy testing is on file with the United States Nuclear Regulatory Commission, as a Master Protocol.
1
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O 2.
Patient Selection Cooperative and reliable patients, who are stable, and non-mobile members of the community, will be selected to assure accurate long-term follow-up reporting.
3.
Follow-Up and Reporting The physician or hospital will be required to contact the patient at 1 east every six months, and report the
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contact to Coratomic.
This contact will be* maintained during the life of ' the patient or until the pacer is re-moved.
"In-person"-follow-up visits are preferable; however, telephone contacts are acceptable.
At the time of follow-up, patients should be reminded of the impor-tance of carrying their I. D. card and wearing their I. D.
jewelry.
Any complications or adverse reactions must be reported to Coratomic by the physician or hospital.
Cor-atomic will consolidate the reporting of patients and notify the Nuclear Regulatory Commission of the results of its accountability program twice per year.
If the patient's whereabouts are unknown, Coratomic will, through its contacts with'the hospitals and physicians, locate the patient and forward this. information to the hospitals to provide complete accountability.
4.
Implantation Procedures and Leads Conventional methods of pacemaker insertion are to be used, ensuring as far as possible that the electrodes and leads used have an expected life comparable to the pace-maker and that they have appropriate pacing thresholds.
In patients with an existing lead, the type of existing electrode must be compatible.
If not, standard. adapters may be used.
Spliced leads may not be used.
-Ideally, Coratomic leads should be utilized to assure long-term compatibility with the pacer materials.
Myocardial or endocardial leads may be used with any of the standard surgical approaches for lead implantation in either the left or the right ventricle.
The C-101-P pulse generator may be implanted in the subcutaneous tissue of the abdo-men, chest wall, the subpectoral muscle tissue of the ches t wall, or*any other area deemed suitable by the responsible physician.
5.
S timulation Threshold Measurements The pacing threshold will be tested for all electrodes, old or new, utilizing a battery-operated, calibrated
(+5% accuracy) pulse generator with an adjustable amplitude and of a pulso duration of
.8 to 1.2 milliseconds.
Only those electrodes may be utilized in which a threshold is demonstrated no greater than 1.5 mA if newly implanted or 4.0 mA if chronically implanted, whether transvenous or epicardial, measured at a pulse width of t
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,.0 milliseconds.
1 6.
Sensing Measuren. ants If possible, the amplitude and width of the patient 's QRS wave should be measured.
Measurement should be be-tween a ground plate in the pacer subcutaneous pocket and the lead terminal distal to the heart.
7.
Registration and Implant Reports Immediately upon implantation of the C-101-P, the physician or hospital will complete a Registration and Implant Data Form, and forward it within 10 days to the Coratomic Data Center.
The form includes identification of the pacemaker, the patient, the physician, the hospital, the heart lead and adapter (if used), stimulated rate, and clinical data concerning the patient and his or her cardiac disease.
The data form is shown as Exhibit II, attached.
8.
Follow-up Data The follow-up datc, reported at six-month intervals, will be prepared by the physician or hospital and sub-mitted to the Coratomic Data Center on the Follow-up Data Form (see Exhibit,III, attached).
This form summa-rizes information on the patient and lists any complica-tions, adverse reactions or pacer malfunction.
"In-person" follow-up visits are preferable; however, telephone contacts are acceptable.
At the time of follow-up, patients should be reminded of the importance of carrying their I. D.
card and wearing their I.
D.
- jewelry, 9.
Reports of Removal and Replacement A special form, " Pacer Failure and Removal or Patient Death," (Exhibit IV) is provided.
This form records all pertinent required data concerning the patient, physician, hospital and reasons for pacer removal and replacement, including whether the failure was of battery, electronic, or lead origin.
Corrective procedures and results of patient ' examinations are also required.
In the event of pacer removal, the pacer must be re-covered and returned to Coratomic.
The hospital and/or the physician shall notify Coratomic,and the licensing agency,of the pacer removal, and Coratomic will send the proper shipping container and instructions to the explanting institution for the pacemaker's return.
10.
Notification of Deaths, Adverse Reactions or Malfunctions Notification of death is included in the form " Pacer Failure and Removal or Patient Death" (Exhibit IV).
The cause of death and autopsy findings are included.
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In the event of patient death, the pacer must be re-
' covered and returned to Coratomic.
The hospital and/or the physician shall notify Coratomic,and the licensing agency, of the patient death and pacer removal within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of such occurrence, and Coratomic will send the proper shipping container and instructions to the explanting institution for the pacemaker's return.
Coratomic will immediately notify the Nuclear Regulatory Commission of the patient death.
11.
Notification of Loss of Patient Contact The hospital must notify Coratomic, and the licensing agency,within ten days of the loss of contact with a nuclear powered pacemaker patient.
This notification can be made on the Follow-up Data Form, Exhibit III, which outlines the reasons for loss of contact and steps taken to reestablish contact.
When loss of contact is reported, Coratomic will immediately notify the Nuclear Regulatory Commission and will pursue the patient using data from the initial implant form (Exhibit II) until a satisfactory explanation is obtained.
Coratomic will advise the hospital of their findings.
12.
Information To and Consent From the Patient a.
All patients accepting the pacemaker must agree to maintain contact with the physician or hospital as summarized above and to the removal and return to the physician (and from them to Coratomic) of the unit upon completion of its expected useful life (40 years), its failure, or upon the patient's death, whichever occurs first.
A legally binding document (Exhibit V) will be signed by the patient, a witness, the patient's spouse, and/or a relative of the patient.
b.
The patient will be required to carry an identifica-tion card as stated in the form shown in Exhibit V.
This card is shown in Exhibit VI.
The card will identify the carrier as a radioisotope powered cardiac pacer patient, will specify the manufacturer and model number of the patient's pacemaker, specify the radionuclides contained in the pacer, and present explicit instruc-tions for notification of responsible parties in the event of accident or dif ficulty.
At the time of follow-up, patients should be reminded of the importance of carrying their I.
D.
card.
The patient will also be required to carry a uniform anatomical Gif t Act Card, as shown in Exhibit VII.
If the patient has not at-tained majority age, the agreement card shown in Exhibit VIII should be executed by the patient where possibic and his or her legal guardian.
c.
The patient will also be required to carry an identi-fication bracelet or other equivalent jewelry of the medical-alert type which will carry the same patient's name and a statement to call the proper emergency e
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telephone number.
At the time of follow-up, patients should be reminded of the importance of wearing their I.
D.
jewelry.
This medical alert jewelry is mentioned in Exhibits III and IV.
d.
The patient will maintain contact with the physician or hospital as discussed in 2 above, and he will be required to agree to do so on the informed consent form of Exhibit V.
The patient _will notify the hospital of any change either e.
in his/her address or in the names and addresses of two persons to be contacted if the patient cannot be located.
The. patient will be required to agree to do so on the informed consent form (Exhibit V).
f.
The patient will be required to notify the hospital of his intention to travel in foreign countries.
The hospital will in turn notify Coratomic, who will notify the Nuclear Regulatory Commission.
The patient agrees to provide this information on the Informed Consent Form (Exhibit V).
13.
Record Retention All pacer records will be maintained separately from the routine hospital records, either by a centralized authority so designated, health physics personnel, or the pacemaker clinic within the hospital's jurisdiction, or the physician responsible for the implantation program.
The hospital or the implanting physician will notify Coratomic of any change in the patient 's address or con-dition so that Coratomic may maintain current records on the patient.
The patient 's chart, both at the hospital and in the physician 's of fice, mus t prominently indicate that the pacemaker must be returned to Coratomic upon its removal from the patient for any reason.
14.
Accountability and Recovery Under a special nuclear material license issued for implanting radioisotopic pacemakers, the patient 's hospital assumes the responsibility for the control, accountability and recovery of the special nuclear materials (plutonium) in the pacemaker.
Conditions for accountability and recovery include the follouing:
a.
The hospital shall not receive or transfer in any single transaction one gram or more of plutonium con-tained in the nuc1 car-powered pacemakers without noti-fying the Division of Safeguards, U.S. Nuclear Regula-tory Commission, Washington, DC 20555, and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CPR Part 70.
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b.
The hospital shall report to Coratomic, Inc. (the manufacturer of the pacemaker), and to the licensing agency,within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear-powered pacemaker patient.
Coratomic will im-mediately advise the Nuclear Regulatory Commission.
c.
The hospital shall report to Coratomic, Inc., and to the licensing agency, within 10 days, the loss of contact with a nuclear-powered pacemaker patient.
Cor-atomic will immediately advise the Nuclear Regulatory Commission.
d.
The implanting hospital should normally be able to follow a patient for life, considering that non-mobile patients are selected and that telephone contacts may be used for follow-up.
In unusual cases where follow-up difficulties are experienced, Coratomic should be con-tacted to try to arrange transfer of responsibility to another hospital.
Responsibility could be transferred to another hospital if:
(1)
The new hospital is properly licensed and agrees in writing to accept full responsibil-ity in accordance with the protocol; (2)
The old hospital transfers responsibility in writing; (3)
The patient signs revised consent forms and receives revised I.
D.
card and I. D.
jewelry; (4)
The appropriate licensing agencies are notified of the transfer and provided copics of the documentation.
Following a proper transfer, the old hospital may of course amend or terminate its license as appropriate.
EXHlBIT l O
O C'
V REFERENCES
- 1. Smyth, Nicholas P, D.. Cardiac Pacemaking. SurgicalDiseases of the Chest, Second Edition m Press.
Editor Brian Blades., C. V. Mosby Co., St. Louis, Mo.,1974.
- 2. Chardack, William M. Cardiac Pacemakers and Heart Block. In Surgery o/ the Chest (Chapter 38),
Second Edition, Editors John H. Gibson, Jr., David C. Sabiston and Frank C. Sper cer W. B.
Saunders Co., Philadelphia, Pa.,1969.
- 3. Furman, Seymour, und Eschcr. Doris J. W.
Principles and Techniques o/ Cardiac Pacirg. Harper and Row, New York, N.Y.,1970.
- 4. Thafen, Hilbert J.: The Arti/icial Cardiac Facemaker: Its History, Development and Clinical Application. C. C. Thomas. Springfield, Ill.,1969.
- 5. Hurzeler, Philip; Decaprio, Vincent; and Furman, Seymour, Montefiore Hospital and Medical Ccnter, New York, N.Y.; Endocardial Electrograms and Pacer Sensing; paper presented at AAMI 10th Annual meeting March 17-18,1975.
1 4
EXHIBIT X INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-100 SERIES ISOTOPIC PULSE GEHERATOR Nuclear Pacemaker Instructions to Operator:
1.
Accept any collect call with reference to a Nuclear Pacemaker.
2.
Any call concerning a Nuclear Pacemaker involves a patient with a nuclear pacemaker and requires imediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacer.
3.
Obtain as much infomation from the caller as is possible including:
Caller's Name and Where he may be Reached.
Patient's Name. Status, and Where he may be Reached.
Attending Physician (if any) and Where he may be Reached.
Infonnation from Patient I. D. Card Patient's Social Security No.
Date of Implant Pacer Serial Nunber 4.
Notify immediately: _
Name, address, telephone number of physician responsible if he cannot be reached, notify:
Name, address, telephone number of alternative physician.
If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear pacer; and advise him of the infomation you have and the urgency of the matter.
4 4
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EXHIBIT IX (continued) 9.
Describe the applicant's procedures to assure notification of appropriate individuals upon receipt of an emergency report of inquiry concerning a pacemaker bearer.
Include written instructions to be given to telephone opera tors.
10.
Confirm that the physicians responsible for and participating in the implantation program represent that they are familiar with the Coratomic C-101-P Protocol and the Coratomic C-101-P Pacer and understand issuance of a license is conditional upon the following of this protocol.
11.
Confinn that the applicant institution agrees to continue the follow-up reporting and recovery procedures during the life of the patient and until the' pacemaker is recovered and returned to Coratomic, Inc.,
P. O. Box 434, Indiana, PA 15701, even in the event the physicians named in the application are no longer associated with the applicant.
12.
Confirm that packaging, labeling, and shipping instructions to be furnished by Coratomic, Inc. will be followed upon the return of the pacemaker for approved disposal.
13.
The applicant hospital or medical institution hereby requests a license to receive, possess, store, and implant the Coratomic C-101-P nuclear powered pacemaker in accordance with this application.
Sig.ied: Appilcant:
(Hospital or Medical Institution)
By:
(nate and title of individual signing on behalf of the applicant)
Physicians responsible for implantation program:
(Letter shoula De signea by both an of ficer of the applicant and the physicians responsible for the implantation program.
Type or print names under signatures.)
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EXHIBli IX SUGGESTED APPLICATI0ff FORMAT FOR NUCLEAR POWERED CORAT0ff!C C-101-P ISOTOPlc PULSE GENERATOR Send to:
Material Licensing Branch U. S. Nuclear Regulatory Connission Or - Agreement State Licensing Agency Washington, DC 20555 (if appropriate)
Re:
Application for license to participate in the implantation of Coratomic of Pu-238(<4.3 curies).C-101-P nuclear powered pacemakers, each c Gentlemen:
The following information is submitted in appilcation for a license to participate in the implantation of Coratomic C-101-P nuclear powered pacers.
1.
Applicant:
(Hospital or )kdical Institution)
(Address)
(State and Zip Code) 2.
Physicians responsible for implantation program: (Provide this infor1 nation for EACH physician involved)
Name:
Office Address:
Telephone Number:
State Licensed in bhich to Practice:
Specialty Board Certification:
Position with the Applicant:
Previous experience in the implantation and follow-up of pacemakers by physician:
(include duration of pacemaker experience, total ntsnber of implants physician has done, and the total nurt>er he has done at the applicant's facilities.)
3.
Protocol to be followed:
HtMAN IMPLANTATION PROTOCOL FOR THE CORAT0ffic C-101-P POWERED CARDIAC PACER. DATED MARCH 2.1983.
4 A maximum of _ Coratomic C-101-P pacemakers is requested to be implanted annually.
5.
Description of physical facilities and equipment at the applicant institution or hospital:
(include description of cardiac care unit and operating facilities and Itst specific equipment needed and available for the implantation threshold parameters, and overall pacemaker function.) inc program; 6.
Description of applicant's present pacemaker implantation and follow-up (Include size.1. e.. number of patients, and duration.)
program:
7.
Describe methods applicant will establish to maintain records of implantation and follow-up of patients separate from routine hospital records.
(Include procedures for assuring continuity of follow-up and determining any possible loss of follow up wit,h a patient.)
8.
Confirm that the applicant institution or hospital will establish 4
appropriate control procedures to insure the physical security of the pacemakers while in the possession of the applicant.
These procedures will include keeping track, by sertal number of the location of each used to guard against loss or theft. pacemaker and requiring that they be Confirm that all activities will be Federal Regulations. Part 70. conducted in accordance with the regulations u (continued next page)
I EKHIBIT Vill DONOR CARO FOR HINORS CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR (Front)
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DONOR CARDS FOR ADULTS CORATOMIC C-100 SERIES PULSE GENERATOR (Front)
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EKHIBIT VI PATIENT IDENTIFICATION CARDS CORATOMIC C.100 SERIES ISOTCPlc PULSE GENERATORS (Front)
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EXHIDIT V INFORMED CONSENT FOR SURGICAL If1 PLANTATION OF RADI0 ISOTOPE POWERID CARDI AC PACER CORATOMIC C-100 SERIES IS010pic PULSC GENERATOR I understand that for the treatment of my cardiac condition - a disturbance of normal cardiac conduction - a cardiac pacer is to be implanted in me.
I understand that the surgical procedure may/will require the implantation of a new electrode or lead into or onto the surface of my ' heart. While the surgical procedure is not of unrwasonable risk, the possibility of complications or even death exist.
The procedure has been explained to me, and I have had the opportunity to ask any questions concerning it.
I understand that the pacer to be used for the implantation is a radio-isotope powered cardiac pacer manufactured by Coratomic. Although the pacer has been extensively tested, there is no assurance that its components will last the full design life. On the basis of past experience, units of this type are expected to have a reliable Ilfe expectancy in excess of 40 years. I understand that the cardiac pacer does produce radiation, but that this radia-tion is negligible.
Since the device contains radioisotope material (Plutonium-238), ultimately, af ter my death or earlier, if the useful life of the pacer is exceeded, if it ceases to function effectively for my medical needs, or if I request to have it removed, the pacer must be returned to Coratomic via (licensed institution). Accordingly, I agree to contact (institution) at least every six months, and whenever I change my residence.
I will always carry the appropriate identificattun card on my person, and will at all times carry the Uniform Anatomical Gift Act donor card and wear either a medical alert bracelet or its equivalent.
Notwithstanding my contacting the implanting institution following the insertion of a cardiac pacer of any sort, I am advised to remain in contact with my personal physician.
I agree to notify the hospital, who will, in turn, notify Coratomic of my intention to travel in foreign countries.
the Nuclear Regulatory Consnission.
Coratomic will, in turn, notify I agree to provide the hospital with the names, addresses, and telephone numbers of two persons to be contacted if I cannot be located. I also agree to notify the hospital of any changes in the nanes, addresses, or telephone nunters of the two persons to be contacted, I agree to maintain contact with my physiciar, at least every six months following the insertion of the pacer, furthemore, I consent to disclosure by the clinic or Coratomic of any infomatinn acquired by the clinic in regard to the implantation of the radioisotope powered cardiac pacer, provided, however, in no event shall disclosure other than to Coratomic include my identification without my specific written approval.
I have had the opportunity to ask questions pertaining to the surgical procedure, the radioisotope powered cardiac pacer, and the follow-up procedure.
The possible alternate methods of treatment, including the use of conventional chemical battery peered pacers have been called to my attention.
With these facts in mind and intending to be Icgally bound, I hereby authorize the surgical procedure whereby the Coratamic radioisotope powered pacer will be implanted in me waiving the right to claim that such procedure was not properly authorized, and I agree to the follow-up procedures and to the ultimate return of the unit as detailed above.
Witness (Date) Ettent's signature or person (Date) authorized to consent for the patient Relatf or. ship ta too patient signing if Please sign 3 copies other than the patient I copy to patient 1 certify that I have explained the I cnpy to hospital above procedure I copy to Coratomic b7.~~
(Date)
~ ~ ~
L,_.__.________
n
)
EXsBli IV IMPORTANT: The isotopic PACER FAILURE AND REMOVAL pacemakeF must be recovered OR PATIENT DEATH FORM and returned to Coratomic CORATOMIC C-100 SERIES ISOTOPIC PULSE GENERATOR in the event of patient death or pacemaker removal.
Please complete this form.
CORATOMIC,INC.
Please contact Coratomic Retain one copy for your DATA CENTER fur proper shipping records and return one P. O. Box 434
__contai ne r, copy to:
Patient Name Las t fi rs t initial Social Security No.
Patient llospital Record No.
Pulse Generator Serial No.
Date of Follow-up
~.Date of implantation Name of Physician Name of Hospital Telephone No.
Address City State Zip Patient has 1. D. card:
Yes No Patient is wearing Bracelet orTt's EquivaTent:
Yes No How was pacemaker disposed of?
2.
Pacer Failure Battery Failure Lead Failure Electronics Failure Description of FaITure __
~
~~
Corrective Procedure Due to'Tallure
~'
Replaced Pacer Model and SeriaTTumber of Replacement Replaced Lead Model and SeriTNumber of Replacement Lead 3.
Patient Death
~
Causes of Death Autopsy findings,
Was Pacer functioning at time of death 7 Ves No Was lead functioning at time of death? Yes 70
~
4 Sunmary of Medical Examinations (if other tFIaii deaM O
.==
em
.g +
e = ~ + - + -. * - -
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- ~ * * "
O
.I e.
EKhlBli 111 l'TMPORTANT: The isotopic FOLLOW-UP DATA FORM paTeinaker must be recovered i
CORATOMIC C-100 SERIES ISOTONC FULSE GENERATOR,. and returned to Coratomic l
l death or pacemaker removal.
in the event of patient Please caplete this fonn.
CORATOMIC, INC.
8 Retain one copy for your DATA CENTER Please contact Coratomic records and return (within
,P. O. Box 434 for proper shipping 10 days) one copy to:
Indiana, PA 15701 contai ne r.
1.
Patient flame Last First Initial
~
Social Security No.
Hospital Record No.
Home Address A/C & Phone Business Address A/C &' Wo~rie~~
Ge, address, and telephone of person (s) to be contacted if patient cannot be located A/C & Phone _
Relationship to Patient Name, address, and telephone of alternate person (s) to be contacted if patient cannot be located A/C l Phone Relationship to Patient 2.
Physician (s)andHospital:
Name Office Address A/C & Phone ~
3.
Radioisotope Powered Pacer Infonnatinn:
Serial No.
Date of implant Date of Follow Up Was follow-up an "in-person" visit or telephone contact?
Was patient reminded of the importance of carrying 1. D. card and wearing
- 1. D. jewelry?
Yes No Patient has 1. D. card Yes No Patient is wearing Bracelet oFTts EquTvilent:
Yes No C-100 Series Pacer Infonnation: Satisfactory -
Unsatisfacto7y ~
s Stimulation Rate:
with Magnet without fiagnet __
List any compilcations, adverse reactions, or pacer nalfunction:
Has any repair, relocation or replacenent of leads been necessary? yes/no Has satisfactory contact been maintained with the patient for follow-up and accountability purposes?
Yes No if no, why was contact lost?
What steps have been taken to re-establish contact? _
O I
EXH1'Bli 11
' M RTAf4T:
REGl5TRAT10N AND INPLANTATION DATA FOR!t
~
The isotopic pacemaker must be recovered CORATOMIC C-100 $(RIES ISOTOPIC PULSE GENERATOR and returned to Coratomic in the event of patient Please complete this form.
CORATOMIC, lHC.
death or pacemaker removal.
Retain one copy for your DATA CENTER Please contact Coratomic records and return (within P. O. Box 434 for proper shipping 10 days) cne copy to:
1ndiana, PA 15701_ container.
(please print or type) 1.
Patient Name Last First Initial Social Security No.
,_ Hospital Record No.
Home Address l
~~f
(
~ /C~f Th'o'ri~~~
Eusiness Address l
~
- ~ ~f
~
Name, address, and telephone 'oTpYr's~o'n[s)fCTYho'nT to be contacted if pattent cannot be 1ccated Relationship to Patient
~
"~
Name, address, and telephone of alternate person (s) to be contacted if patient cannot be located
~ /C & Phone A
blationship to Patient 1
2.
Physician (s) and HospitaTI~'
~ ~ ~
Name Office Address A/C & Phone 3.
E.dioisotope Powered Pacer Information:
Serial No.
Date of l@lant Placement: s ubc u ta neous /s ubmus cu la r/ i n t ramus c u'Ta r/o the r
~
right/left pectoral / abdominal /other existing /new pocket 5timulation rate: with Magnet without __
Threshold measurements: voltage current
' pulse width other method (describe):
~
Equipment used to measure threshold _
4.
Previous Iglant Information:
Yes fio If yes:
flanufacturer Model Date of implant l
Why removed Total number or previous implants 5.
Lead: Manufacturer M~ofeTho. ~
Serial No. (for new leads only) _..
0 ate of implant Placement: Myocardial: right/left ventricle transthoracic /transmediastinal Endocardial:. vein used Previous leads (if appilcable and available):
Myocardial: Nanber, models, and implant dates; how many removed?
Endocardial: Number, models, and implant dates; how many removed?
6.
Clinical data:
l Patient's age Sex __
Race Height I
Weight Right handed /Left handed Etiology of arrhythmia Kind of arrhythmia Previous drug therapy for arrhythmia Associated diseases Temporary pacing (for initial implant 5 inly)
Yes No
~
Anesthetics used curing surgery Antibiotics: locally / systemically /none Cortisones or other anti-inflamatory drugs: localJy/ systemically /none Was pocket drained:
Yes No If yes, how long?
Did complications or adverse reactions occur in pacemaker / lead surgery? __
If yes, treatment Coronents
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O O
,o BITWEEN: William 0. Miller, Chief License Fee Management Branch Office of Administration John E. Glenn, Chief Nuclear Materials Section B l
Division of Engineering and Technical Programs i
LICENSE FEE TRANSMITTAL i
Ecc Emmet A.
REGION 1.
APPLICATION ATTACHED Applicant / Licensee:
No rwni\\<
ur.stn4n)
Application Dated:
)) l %c /9;4 Control No.:
()."l220 License No.:
%N M - 604 2.
FEE ATTACHED Amount:
O Check No.:
O 3.
COPNENTS Signed b 9cmdh h knidh Date Qln/94 B.
LICENSE FEE MANAGEMENT BRANCH q
1.
Fee Category and Amount:
O 2.
Correct Fee Paid.
Application may be processed for:
l Amendment Renewal License y
Signed M
^r -
Date I
lI I
REGION I FORM 213 (MARCH 1983)
I
-